FDA Fellowship in Nasal and Pulmonary Drug Delivery and In Vitro Permeability Research

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), located 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. These efforts cover more than just medicines.

Research Project: You will have the opportunity to participate in a multidisciplinary regulatory science project evaluating biorelevant in vitro methods for characterizing the performance of nasally administered drug products. The funded project will initially focus on naloxone hydrochloride and nalmefene hydrochloride nasal spray products indicated for opioid-overdose reversal. The research will investigate whether regional nasal deposition, epithelial permeation, and drug–mucus interaction measurements can generate evidence relevant to the development of alternative bioequivalence approaches for generic products that are not qualitatively and quantitatively the same as their respective reference products.

Learning Objectives: Under the guidance of FDA mentors, you will have opportunities to:

• Develop a mechanistic understanding of nasal and pulmonary drug delivery, including the effects of formulation, device performance, regional deposition, mucus interactions, and epithelial barrier properties on drug absorption.
• Gain hands-on experience designing, conducting, troubleshooting, and interpreting in vitro permeability and transport studies using relevant nasal or pulmonary epithelial cell and tissue models.
• Develop experience with respiratory cell culture and model characterization.
• Learn approaches for evaluating assay suitability, barrier integrity, recovery or mass balance, reproducibility, variability, model limitations, and the biological relevance of permeability measurements.
• Participate in biorelevant characterization of naloxone hydrochloride and nalmefene hydrochloride nasal drug products.
• Learn how in vitro deposition and permeability data may be integrated with formulation and device attributes and may inform future computational fluid dynamics or physiologically based pharmacokinetic modeling.
• Strengthen competencies in experimental design, quantitative data analysis, scientific documentation, multidisciplinary collaboration, technical writing, and presentation of regulatory science research.

Mentor: The mentor for this opportunity is Ross Walenga (Ross.Walenga@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date: November 2026. 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.

Participant Stipend: The participant will receive a monthly stipend commensurate with educational level and experience. 

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.