FDA Biologics Testing Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Clinical Pharmacology, Office of Translational Sciences, 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.
The ability to test biologics for safety and efficacy in animal models is limited by differences in biological receptors between species. The potential contribution of human-specific immune responses to the development of immunotoxicity and tissue injury hampers the assessment of product safety. Therefore, it is of critical importance to develop and validate in vitro and in vivo models that can improve FDA's ability to predict and characterize potential clinical issues in metabolism, safety and product efficacy prior to human testing.The selected participant will be involved in the testing of biological drug products that are of regulatory significance to CDER using in vitro and in vivo models, including humanized mouse models.
The participant will be involved in several of the following aspects of the project:
- Experimental design, testing and assessment of biologics and/or biosimilars
- Multi-parameter flow cytometry
- ELISA (MSD & Luminex), ELISpot, cell isolation & culture
- Assessment of pharmacokinetics (PK) and pharmacodynamics (PD)
- Surgery to humanize severely immune-compromised mice
- Data analysis, literature review and manuscript preparation
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.