*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) 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 objective of this study is to establish the pharmacokinetic/ pharmacodynamic disease mode of various bispecifics in order to facilitate future regulatory decisions on clinical trial design and dosing regimen selection for bispecific antibodies in the treatment of auto immune diseases. This research project will also use a physiologically based pharmacokinetic (PKPD) modeling approach to characterize the PK of oral inhalation drug products, evaluate the impact of intrinsic and extrinsic factors on the PK of oral inhalation drug products, and explore the relationship between systemic exposure and safety and efficacy.
During this project, the participant will learn how to develop and apply quantitative analysis to build a PKPD model to evaluate the exposure response relationship for bispecific antibodies in the treatment of auto immune diseases and solve regulatory and drug development questions.
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 four 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.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.