Research Project Description
Renal Transporters and Toxicity Fellowship
Division of Clinical Pharmacology IV
Office of Clinical Pharmacology
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, MD
A fellowship opportunity is currently available in the Division of Clinical Pharmacology IV within the Office of Clinical Pharmacology (OCP) at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA).
OCP’s mission is to assure the safety and effectiveness of new drugs through the evaluation of clinical pharmacology and biopharmaceutics data in support of CDER’s Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) review programs.
Serum creatinine (sCr), an endogenous marker, is routinely measured during drug development and often assessed in clinical practice to monitor renal function. The estimated creatinine clearance, computed using sCr, is also used in practice to guide dosing in patients with renal impairment for certain drugs if dose adjustment is warranted. An increase in sCr, coupled with information on various renal injury markers, is used as an indicator of renal toxicity. However, creatinine is a substrate of several renal transporters such as Organic Cation Transporters (OCTs) and Multi-Drug and Toxin Extrusion Transporters (MATEs). Hence, inhibition of these transporters by medications may result in decreased active renal secretion of creatinine and a subsequent increase in sCr without underlying renal toxicity.
This project will focus on addressing regulatory questions related to assessing renal toxicity, evaluating the drug-drug interaction potential of the investigational drugs that are inhibitors of renal transporters, and exploring the utility of physiologically based pharmacokinetic (PBPK) modeling to predict the in vivo impact of inhibition of renal transporters by medications.
The Research Participation Program for FDA is administered by the Oak Ridge Institute for Science and Education (ORISE). 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 depending on educational level and experience. The participant must show proof of health insurance. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA or the program administrator, and there are no fringe benefits paid.
- A Doctoral degree in pharmacy, medicine, or a scientific field received within the last five years.
- Students currently pursuing a Master’s or Doctoral degree in the aforementioned fields at an accredited U.S. college or university are also welcome to apply. Proof of enrollment will need to be provided each semester.
- Experience in the area of drug transporters and PBPK modeling is highly desirable.
How to Apply:
To be considered, please send a current CV/resume to the attention of FDArpp@orau.org. Please reference FDA-CDER-2014-0041 in all communications.