FDA Antiretrovirals in Pregnancy: PBPK Modeling ORISE Fellowship

A research opportunity is currently available in the Office of New Drugs (OND)/ Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM) at the 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.

Pregnancy-specific pharmacokinetic (PK) data to inform drug dosing for pregnant women are lacking, posing potential risks to the health of mother and fetus. Bridging this gap is critically important for pregnant women living with HIV who take antiretroviral drugs to suppress HIV replication and reduce the risk of HIV transmission to the fetus. Physiologically-based (PB) PK modelling in pregnancy has been limited by the unavailability of data. This project leverages the unique and extensive PK database from the NIH-funded International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Network studies P1026s and 2026 to systematically evaluate the predictive performance of pregnancy PBPK models, while identifying and addressing knowledge gaps.

Under the guidance of the mentor, the participant will learn PBPK modeling software (i.e., SimCYP and Open Systems Pharmacology), and gain an understanding of the drug regulatory review process and other regulatory activities relevant to maternal health, pharmacometrics, and antiviral areas. It will strengthen the participant's statistics knowledge through PK data analysis. The participant will develop a scientific poster and provide oral presentations to a scientific audience.

 

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.

The qualified candidate should be currently pursuing or have received a master's or doctoral degree in one of the relevant fields listed in the ad. Degree must have been received within the past five years.

Preferred Skills/ Knowledge: