FDA Biopharmaceutics for Quality Standards Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Pharmaceutical Quality/ Office of New Drug Products (ONDP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
The Center for Drug Evaluation and Research (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 U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
This project aims to use biopharmaceutics tools to understand the in vivo risk associated with drug products and establish patient-centric drug quality standards; specifically, the use of modeling and simulation coupled with in vitro dissolution testing will be employed for biopharmaceutics risk assessment and setting of quality standards. Such an enhanced understanding on biopharmaceutics risk will support guidance and policy development needed for ensuring high quality drugs across their life cycles.
Under the guidance of a mentor the participant will train on conducting relevant data searches and analysis to collect quality data on a number of drug products. The participant will also learn the basics of drug product development and the control strategies for drug product quality. Most importantly, the participant will learn the use of biopharmaceutics tools (in vitro dissolution testing, PBPK modeling, IVIVC) in product development and regulatory approvals.
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.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.