*Applications will be reviewed on a rolling-basis.
A research opportunity is currently available at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality/ Office of Biotechnology Products (OBP) located in Silver Spring, Maryland.
Polyethylene glycols (PEGs) are nonionic polymers of ethylene oxide commercially available over a wide range of molecular weights from 200 to 40 kD and used in thousands of medical and pharmaceutical products (either as active ingredients or excipients) including mRNA COVID vaccines. Despite the success in achieving improved pharmacokinetics, PEG and PEGylated drugs have a small but significant rate (reported from less than 0.1% up to 9%) of acute allergic reactions, many upon first treatment with the PEGylated drugs. The research project is to understand the relationship between PEG product quality attributes and the potential risk of allergenic reactions.
Under the guidance of the mentor, the participant will learn to apply state of art Double Cytometry Beads Assay (DCBA) to test anti-PEG IgE in patient samples. In addition, the participant will also learn to apply in vitro Type I hypersensitivity models and culture of mast cells.
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.