FDA Evaluating Time-Course of Anti-Drug Antibodies Therapeutic Proteins Fellowship

How To Apply

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• 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.

6/30/2026 3:00:00 PM Eastern Time Zone

Applications will be reviewed on a rolling-basis.

A research opportunity is available immediately in the Office of Combination Products (OCP) / Office of Translational Sciences (OTS), within the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA), 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. This effort covers more than just medicines.

Immunogenicity assessment traditionally relies on a multi-tiered testing strategy to detect anti-drug antibodies (ADAs), involving sequential screening, confirmatory, and titer assays. Recently, the signal-to-noise ratio approach has emerged as a promising alternative for ADA evaluation. Compared to the conventional tiered methodology, the signal-to-noise approach offers greater precision than traditional titer assays and has the potential to streamline immunogenicity testing by consolidating the multi-tiered process into a single, more efficient method.

While the signal-to-noise ratio approach demonstrates clear advantages, additional research is needed to establish its utility for quantitatively characterizing ADA time‑course profiles compared to traditional tiered approaches.

• Survey the FDA-approved therapeutic proteins and identify those with immunogenicity assessments with titer and signal-to-noise ratio to further assessment
• Collect and summarize individual subject immunogenicity data from FDA internal databases
• Develop a population model with these data using a nonlinear mixed‑effect modeling approach and perform sensitivity analysis
• Evaluate the relationship between the change in individual level of immunogenicity over time and the change in population level internally and externally

Through participation in this research opportunity, you will develop a comprehensive understanding of immunogenicity and its clinical impact from a quantitative perspective, gain hands‑on experience with data analysis and integration of internal database to inform regulatory assessments, and strengthen critical‑thinking and scientific communication skills to support evidence‑based decision‑making in drug development. Under the guidance of a mentor, structured learning opportunities for you will include:

• Training in data extraction, interpretation of clinical pharmacology review documents, and literature synthesis
• Opportunities for manuscript or internal report preparation, presentation skills, and cross-disciplinary collaboration
• Applying modeling skill in helping regulatory decision making
• Participation in seminars on clinical pharmacology, pharmacometrics, and regulatory science
• Networking with experts across therapeutic areas, supporting career planning and professional growth

The mentor for this opportunity is Ping Ji (ping.ji.gov). If you have questions about the nature of the research, please contact the mentor.

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

The appointment will initially be for one year, but may be…