FDA Fellowship in Cross Protection Against Enteroviruses

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is currently available in the Office of Vaccines Research and Review (OVRR) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

The ORISE Research Participation Program at the U.S. Food and Drug Administration is an educational and training program designed to provide college students, recent graduates, and university faculty opportunities to connect with the unique resources of the FDA. With the support of an assigned mentor, participants have authentic hands-on research experience and allows them access to unique research opportunities, top scientists and engineers, and state-of the art facilities and equipment. The Center for Biologics Evaluation and Research (CBER) is one Center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services. CBER's mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.

Research Project: Enterovirus D 68 (EV-D68) is an enterovirus that is genetically and biochemically related to poliovirus and human rhinoviruses. While EV-D68 is a respiratory pathogen, epidemiology studies suggest that it is also an etiologic agent of acute flaccid myelitis (AFM), a childhood polio-like paralysis. Our published work suggests that all isolates of EV-D68, from 1962 to 2014 are neurotropic. (Rosenfeld, et al. mBio 2017). To understand the mechanism of neuroinvasion, an immune competent mouse model of EV-D68 infection is needed.

This research project will leverage our published and unpublished data that showed EV-D68 reproduction in organotypic brain slice and airway-liquid interface cultures derived from wild type mice. The applicant will adapt EV-D68 isolates to mice by serially passaging virus between these cultures and in vivo infectious of mice via intracranially and intranasal inoculation. Additionally, the applicant will generated infectious DNA copies of the genome of each EV-D68 isolate, in order to produce chimeric viruses to identify the amino acids that mediate host specificity of virus reproduction. The findings are expected to be presented to at the American Society for Virology and submitted to peer-reviewed journals for publication.

Learning Objectives: The fellow will learn the principals of experimental design and analyses; fundamentals of immunology and immunological assays; and fundamentals of microbiology and infectious disease animal models.

Anticipated Appointment Start Date: June 20, 2024.  Start date is flexible and will depend on a variety of factors.

Appointment Length: The appointment will initially be for one year but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

Level of Participation: The appointment is full time.

Citizenship Requirements:  This opportunity is available to U.S. citizens only.

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 participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. 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 Ethics Requirements

If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists. 

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.

Qualifications

The qualified candidate should have received a bachelor's degree in one of the relevant fields. Degree must have been received within the past five years. 

Eligibility Requirements

• Citizenship: U.S. Citizen Only
• Degree: Bachelor's Degree received within the last 60 month(s).
• Academic Level(s): Post-Bachelor's or Undergraduate Students.