FDA Postdoctoral Fellowship - Biopredictive Dissolution Development for Oral Peptides

Research Project

This fellowship will provide training through participation in regulatory science research focused specifically on developing biopredictive dissolution methods for oral peptides. The goal is to unlock the potential of predictive biopharmaceutical tools that enable regulatory flexibility. The research outcomes will also support updates to dissolution guidance documents.

Fellowship Activities

• Evaluating formulation and process variables that influence dissolution behavior
• Contributing to the development and assessment of discriminating and physiologically relevant dissolution methods
• Exploring relationships between in vitro dissolution behavior and in vivo absorption-relevant processes
• Applying advanced analytical approaches to characterize peptide release and performance
• Contributing to evidence generation that supports scientifically sound frameworks for biopredictive dissolution method development

Learning Objectives

• Gain hands-on experience in dissolution method development, analytical characterization, experimental design, and mechanistic interpretation of oral peptide performance
• Exposure to advanced dissolution methodologies, principles aligned with ICH Q14 analytical development concepts, and approaches for linking in vitro data to the in vivo performance attributes
• Participation in scientific seminars, interdisciplinary discussions, and collaborative research activities related to complex drug product evaluation
• Develop an understanding of scientific factors governing dissolution and in vivo performance of oral peptide formulations
• Gain competency in development and evaluation of discriminating and biopredictive dissolution methods
• Build familiarity with regulatory science considerations relevant to complex product performance assessment
• Gain experience communicating research findings through technical reports, presentations, and potential publications

Mentor

The mentor for this opportunity is Hailing Zhang (hailing.zhang@fda.hhs.gov).

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.

Qualification

The qualified candidate should be currently pursuing or have received a doctoral degree in the one of the relevant fields.

Preferred Skills/Knowledge

• Strong analytical capability
• Pharmacy/pharmacology related knowledge is preferred