*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Division of Applied Regulatory Science (DARS) at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), located in Silver Spring, Maryland. 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 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. The project will help validate in vitro methods and in vivo models that can improve FDA's ability to predict and characterize potential immunogenicity to the drug product as well as issues related to safety and efficacy prior to human testing.
Under the guidance of the mentor, the participant will be involved in: 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; and data analysis, literature review and manuscript preparation
Anticipated Start Date: 2022. The start date is flexible and will depend upon a variety of factors.
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.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
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.
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