Pharmacology and Pharmacometrics Core

ABSTRACT – JHU TRAC PHARMACOLOGY AND PHARMACOMETRICS CORE (PPC) The Pharmacology and Pharmacometrics Core (PPC) will foster the creation, implementation, and conduct of new tuberculosis (TB) therapeutics research, harnessing existing and new physical and human resources, in the furtherance of: 1) Clinical and translational pharmacology-informed drug evaluation and development; and 2) Education and development of New Investigators (NI) in this field. There is a need for new and better therapeutics for the treatment of TB. Understanding pharmacokinetic-pharmacodynamic (PK/PD) relationships is key to advancing drug development and being able to develop rational therapeutics and successful treatment for all by determining the right drug at the right dose for the right patient. The PPC will provide added value to the JHU TRAC by offering state-of-the-art analytical chemistry support for the development and use of drug assays of biological samples, clinical and translational pharmacology support for design of pre -clinical and clinical studies, and quantitative pharmacology support for analysis, interpretation, and integration of preclinical and/or clinical data to support NI and established investigators studying novel aspects of TB treatment. The PPC is led by Drs. Kelly Dooley (Director, Clinical Pharmacology) and Michelle Rudek (Co-Director, Analytical and Clinical Pharmacology) at JHU, with senior leadership input by Dr. Eric Nuermberger (JHU, Translational Pharmacology) and Dr. Joga Gobburu (Pharmacometrics) at the University of Maryland. This team has several decades of combined experience in pre-clinical and clinical pharmacology. The specific aims of the PPC are to: 1) Provide consultative clinical and translational pharmacology support for JHU TRAC, and assist and mentor investigators in the design and conduct of preclinical and clinical studies focused on TB therapeutics; 2) Provide state-of-the-art, Good Laboratory Practice (GLP)-quality evaluations to quantify drugs (and metabolites) to treat TB in biological samples; and 3) Provide PK and PK/PD data analysis and interpretation to support translational and clinical projects involving TB drugs, and to support decision-making for safe and efficient drug development. The PPC will synergize with the TRAC by providing support and training opportunities for NI/ESI recipients of Developmental Awards involving studies with PK/PD components, and by participating in the weekly TRAC Seminar Series, the TRAC-specific Writing Accountability Groups (WAGs) for NI/ESI, the TRAC K-Club and K2R Club, the annual TB Scientific Meeting and TRAC Data Fair. The PPC investigators look forward to applying their collective expertise to benefit TB clinical care by promoting innovative approaches to TB treatment and accelerating experimental therapeutic agent development.