FDA Research - Dose Selection of Products Inflammatory Bowel Disease

How To Apply

To submit your application, scroll to the bottom of this opportunity and click APPLY.

• 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.

FDA-CDER-

4/30/2026 3:00:00 PM Eastern Time Zone

Applications will be reviewed on a rolling‑basis.

A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), located in White Oak, Maryland. CDER performs an essential public health task by ensuring 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.

These efforts cover more than just medicines.

This project will investigate strategies for optimizing pediatric dose selection to streamline pediatric drug development for inflammatory bowel disease (IBD). Since the approval of infliximab for Crohn’s disease in 1998, multiple advanced therapies—ten biologics and four small molecules—have been approved for ulcerative colitis (UC), Crohn’s disease (CD), or both in adults. However, the approval of these products for pediatric patients has progressed more slowly due to the inherent challenges of conducting pediatric studies and the widespread off‑label use of adult therapies.

To date, only three products have been approved for pediatric IBD, including recently approved golimumab (October 2025). In the meantime, the American Gastroenterological Association (AGA) has recommended therapeutic drug monitoring for certain TNF‑α antagonists, though these recommendations are based on low‑certainty evidence and clinical dose optimization for adults with IBD continues to be debated. The agency recommends well‑established dose‑exposure‑response relationships in adults to inform pediatric dosing, with pediatric efficacy evaluated in pediatric populations.

Conversely, in the case of adalimumab, pediatric UC studies employing two dose levels have supported the approval of pediatric doses higher than the corresponding adult doses. These observations highlight the need for improved, evidence‑based dose‑selection strategies for both adult and pediatric IBD patients.

To identify and evaluate approaches that can better inform pediatric dose selection based on adult data and patient‑specific factors. Specifically, the Fellow will:

• Survey clinical development programs for IBD products, focusing on dose‑selection strategies for adults and pediatric patients.
• Collect and analyze data from FDA reviews, internal databases (as available), and relevant published literature.
• Compare approved doses between adult and pediatric populations and across indications when products are approved for multiple diseases.
• Investigate how patient factors—such as age, body size, disease activity, and immunogenicity—affect pharmacokinetics (PK), pharmacodynamics (PD), and therapeutic dose selection for IBD.
• Identify best practices and gaps in dose‑selection methodologies to support regulatory decision‑making and future pediatric drug development strategies.

• You will meet regularly with your FDA mentor and a project team to discuss progress, data interpretation, and methodological approaches. Additional learning opportunities will include participation in FDA seminars, workshops, and lectures open to fellows.
• You will develop a comprehensive understanding of IBD pathophysiology, therapeutic mechanisms, and clinical management, including therapeutic drug monitoring and dose optimization, and understand the principles of pharmacokinetics and pharmacodynamics as applied…