FDA Evaluating Pharmacokinetic Profile of Long-Acting Injectables in Pregnant Individuals

Organization

U.S. Food and Drug Administration (FDA)

FDA-CDER-

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A Complete Application Consists Of

• An application
• Transcripts –  for detailed information about acceptable transcripts
• A current resume/CV, including academic history, employment history, relevant experiences, and publication list
• One educational or professional recommendation

All documents must be in English or include an official English translation.

If you have questions, send an email to ORISE.FDA.CDER. Please include the reference code for this opportunity in your email.

4/30/2026 12:00:00 AM Eastern Time Zone

Applications will be reviewed on a rolling-basis.

A research opportunity is available immediately within the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM) / Office of New Drugs (OND), in the Center for Drug Evaluation and Research (CDER), at the 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.

Despite successful oral treatment options for patients, there is major concern related to inadequate patient adherence which leads to treatment failures and relapse of chronic disease. Long-acting injectable (LAI) drug products are being developed to overcome inadequate drug adherence and associated treatment failure. Given the paucity of data in pregnancy and lactation, model-based approaches (such as physiologically-based pharmacokinetic (PBPK) modeling) are being employed to understand the pharmacokinetics (PK) of drugs in these populations.

This project utilizes PBPK modeling and leverages the limited available PK data from opportunistic PK studies and publicly available information of LAI products to:

• evaluate the PK of drugs in different trimesters of pregnancy;
• predict the fetal exposure to drugs;
• evaluate drug transfer into breast milk;
• predict the exposure to drugs in the breastfed infant.

This project focuses on development of PBPK models for LAI drug products (e.g., antiretroviral drugs and psychiatric drug products).

The anticipated project outcomes are at least two PBPK maternal models to predict the PK profile of LAI drug products (i.e., cabotegravir, aripiprazole) in pregnant and lactating people. These PBPK models will help predict drug exposure during pregnancy and lactation where data generation is historically slow and sparse. The expected regulatory utility is that these models may be used to optimize and/or prioritize the design of PK studies with LAI in these populations, to further evaluate the clinical experience during pregnancy and lactation, and to contribute to safety recommendations for drug product labeling.

The models could also be used to identify key physiological parameters responsible for altering the PK of LAI in pregnancy and lactation.

Under the guidance of the mentor(s), the participant will develop the following skills during the fellowship:

• Learn the steps of development and validation of PBPK models for drugs and populations (i.e., pregnant women, lactating women);
• Conduct clinical PK data analysis and interpretation of clinical/model-based PK data in the context of dosing and safety;
• Collaborate with PBPK experts both within and outside the FDA;
• Gain an understanding of the drug regulatory review process;
• Develop a scientific poster and provide oral presentations to scientific audiences;
• Contribute to a draft manuscript for publication.

This project provides the participant hands‑on training on model development from PBPK modeling experts at the Agency and experiences to grow as a professional in the drug development field. A successful participant will have gained invaluable skills to launch forward a career in pharmacometrics.

The mentors for this opportunity are Tamara Johnson (tamara.johnson.gov), and Venkateswaran Chithambaram Pillai (venkateswaran.chithambarampillai.gov). If you have questions about the nature of the research, please contact the mentors.

2026. Start date is flexible and will depend on a variety of factors.

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

The appointment is full‑time.

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

This…