FDA Biomarker Analysis: Addressing Gap Patient Enrollment Applications and Pharmaco

Organization: U.S. Food and Drug Administration (FDA)

Office and

Location:

Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), Silver Spring, Maryland.

Investigate the use of biomarkers in multiple roles—diagnostic, pharmacodynamic, and efficacy—across biologics license applications (BLAs) approved from 2015 to 2025. Analyze the associated bioanalytical methods to identify gaps, provide scientific rationale for appropriate bioanalysis, and propose solutions to improve drug development efficiency.

• Navigate the FDA database system.
• Understand how biomarkers support drug development.
• Master bioanalysis of pharmacodynamic biomarkers and industry best practices.
• Appreciate the scientific considerations in regulatory decision‑making.

Xiulian Du (Xiulian.Du.gov) and Yow‑Ming Wang (Yowming.Wang.gov).

• Start date:
  
  2026 (flexible).
• Length: initially 12 months, may be renewed upon recommendation and availability of funds.
• Level of participation: full‑time.
• Stipend: monthly stipend commensurate with educational level and experience.

Open to U.S. citizens, lawful permanent residents (LPR), and foreign nationals. Non‑U.S. citizens must meet the immigration status criteria outlined on the program website.

Applicants must read and sign the FDA Education and Training Agreement within 30 days of their start date. The agreement covers topics including the non‑employee nature of the appointment, prohibition on performing inherently governmental functions, intellectual property rights, and confidentiality obligations.

• Non‑employee nature of the appointment.
• Prohibition on performing inherently governmental functions.
• Obligation to convey FDA rights to intellectual property created during the fellowship.
• Property of research materials and laboratory notebooks.
• Protection and non‑disclosure of non‑public information.

Candidate must be pursuing or have received a Master’s or Doctoral degree in a relevant field within the last five years of the appointment start date.

• Degree:
  Master’s or Doctoral degree received within last 60 months or currently pursuing.
• Discipline:
  Life, Health, and Medical Sciences – Pharmacology.

Ashley