*Applications will be reviewed on a rolling- basis.
A research opportunity is currently available in the Office of New Drugs / Office of Infectious Diseases (OID), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland. CDER performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the FDA, CDER regulates over-the- counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
The project will address multiple challenges with current antimicrobial minimum inhibitory concentration (MIC) based pharmacokinetic- pharmacodynamic (PK-PD) methodologies for clinical decision making. Specifically, identification of the true PK-PD target and consideration of its variability by evaluating different bacterial burden and incorporating unconsidered factors (e.g. PD variability) will be addressed.
Under the guidance of a mentor(s), the participant’s training will include: •Learning to prepare a database describing antimicrobial PK-PD information gathered from submitted marketing applications and publicly available sources including published literature. •Learning to evaluate nonclinical infection PK-PD models and apply the information for translation and selection of the dosing regimen(s) used to support a marketing application as well as set antibacterial susceptibility test interpretive criteria. •Learning to conduct MIC-based PK-PD analyses (e.g., population pharmacokinetics, Monte Carlo simulations).
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.