FDA In Vitro and In Vivo Bioequivalence Fellowship

Overview

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: Research opportunities are available in the Office of Generic Drugs/ Office of Research and Standards (ORS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in multiple locations such as Jefferson, Arkansas, St. Louis, Missouri, Silver Spring, Maryland, or a variety of different laboratories.

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.

Research Project: This research project seeks to identify and develop proposals for novel in vitro, in vivo, or in silico techniques that may be capable of determining whether various complexity factors related to generic drug products will impact their bioequivalence with their reference products. These factors may include complex drug substances and formulations, as well as device-related considerations capable of impacting product performance and bioequivalence. Specific research may also involve relevant human factors research and human pharmacokinetics (PK) or clinical endpoint studies.

Learning Objectives: Under the guidance of the mentor, the participant will gain a comprehensive understanding of the scientific and regulatory challenges that must be considered when establishing bioequivalence for complex drug products including drug suspensions, long-acting polymer-based drugs, oral inhaled and nasal products, topical and transdermal drugs, and combination drug-device products with device components that may themselves have degrees of complexity in design. In addition, the participant will gain knowledge in collaborating with cross-disciplinary teams to develop novel in vitro, in vivo, and/or in silico study designs for establishing bioequivalence with these products.

Anticipated Appointment Start Date: 2024/2025.  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, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

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 be currently pursuing or have received a master’s or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.

Preferred skills:

Drug development research or pharmaceutical industry experience
Strong background in written and oral communication including publication history in peer reviewed journals
Prior familiarity with development and analytical testing of complex drug products such as peptides, liposomes, sustained release injectables, dry powder inhalers, ophthalmic suspensions, creams, ointments, transdermal patches, or drug-device design