Jobs

FDA Food Effect Predictions for Extended-Release Drugs Fellowship

Posted on: September 3, 2020 Apply Now
Fellowships and Graduate School Expires March 31, 2021

*Applications will be reviewed on a rolling basis.

A research opportunity is available in the Office of Translational Sciences/Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located in Silver Spring, Maryland.

Currently, the FDA recommends dedicated food effect (FE) studies for all oral extended-release (ER) drug products regardless of the solubility and permeability of the drug substance. This project will identify scientific criteria that could support a waiver of clinical FE studies in developing ER products for high solubility drugs (i.e. BCS class I and III). Specifically, the participant will investigate whether available data such as results from fasted relative bioavailability (BA) studies, preclinical intestinal site-specific drug absorption data, physiologically based pharmacokinetic (PBPK) modeling, and in vitro dissolution data/Caco-2 permeability data can be used to accurately predict the presence and magnitude of FE for BCS class I and III ER drug products.

Under the guidance of a mentor, the participant will develop a deep understanding of the mechanisms of food effects for extended-release formulations and the factors which should be considered in food effect predictions and learn about currently available tools for human food effect prediction. In addition, the participant will learn to investigate and identify the mechanisms of food effect and develop mathematical models to predict food effect on orally administered extended-release drugs.

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 six months, 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 Homeland Security Presidential Directive-12 (HSPD-12) mandates a background check be completed for both U.S. Citizens and foreign nationals. Foreign nationals must have resided in the U.S. for at least three (3) of the past five (5) years in order for FDA to be able to complete a background check.

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:

  • Non-employee nature of the ORISE appointment;
  • Prohibition on ORISE Fellows performing inherently governmental functions;
  • Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
  • The fact that research materials and laboratory notebooks are the property of the FDA;
  • ORISE fellow’s obligation to protect and not to further disclose or use non-public information.

If you have questions, send an email to ORISE.FDA.CDER@orau.org.

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