FDA Fellowship - Efficient Factor VIII Drug Products to Improve the Treatment of Hemophilia A

Research Project

The project will focus on investigating the biochemical mechanisms of blood coagulation to enhance the safety and efficacy of drug products that treat blood coagulation disorders. In joining this project, you will study mechanisms of plasma clearance of blood coagulation factor VIII (FVIII), particularly the respective molecular interactions, and you will learn various methodologies to model and test these interactions in vitro.

Learning Objectives

• Learn the mechanisms of blood coagulation and respective in vitro assays modeling this process.
• Learn the mechanisms of FVIII plasma clearance and master respective protein interaction assays modeling relevant processes in vitro.
• Learn gene/construct design, recombinant protein expression, purification, and testing.
• Learn various structural and functional assays modeling the biomolecule interactions in vitro.

Most Recent Publications

• Shi B et al (2025): Mutations of six amino acid residues in a B domain-deleted blood coagulation factor VIII have a cumulative effect for Increasing its secretion. Res. Pract. Thromb. Haemost. 10(1):103325.
• Sarafanov AG (2023): Plasma clearance of coagulation factor VIII and extension of its half-life for the therapy of hemophilia A: a critical review of the current state of research and practice. Int. J. Mol. Sci. 24: 8584.
• Chun H, et al (2022): Blood coagulation factor VIII and LRP1 interact dynamically via switching alternative canonical bivalent and non-canonical electrostatic contacts. J. Thromb. Haemost. 20(10):2255-69.

Mentor

The mentor for this opportunity is Andrey Sarafanov (Andrey.Sarafanov@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date

The anticipated appointment start date is 2026. Start date is flexible and will depend on a variety of factors.

Appointment Length

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

Level of Participation

The appointment is full-time.

Participant Stipend

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

Citizenship Requirements

This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only.

Program Information

The program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.

Background Investigation

Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.

FDA Ethics Requirements

If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.

ORISE GO Mobile App

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Qualification Requirements

The qualified candidate should be currently pursuing or have received a master's or doctoral degree in the relevant fields.

Preferred Skills/Experience

• Skill in biochemistry and molecular biology, such as designing and cloning plasmid constructs, bacterial and tissue cultural techniques, recombinant protein expression and purification, PAGE/Western blot protein analysis and performing respective functional/binding assays.
• Knowledge of chemical kinetics and surface plasmon resonance technique.

Additional Information

I am a U.S. citizen, or I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)

I have read the FDA Ethics Requirements.