FDA Utilizing Artificial Intelligence to Enhance Rare Disease Research

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available immediately with the Food and Drug Administration (FDA), in The Center for Drug Evaluation and Research (CDER), 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. These efforts cover more than just medicines.

Research Project: As an Oak Ridge Institute for Science and Education (ORISE) participant, you will join and learn from a community of scientists and researchers in an effort to investigate emerging AI methods and technologies that may support rare disease research, drug development, and regulatory science. You will have the opportunity to participate in developing and evaluating analytical approaches for identifying, organizing, integrating, and interpreting information relevant to rare diseases. Additionally, you will assess the utility, performance, limitations, and applicability of emerging analytical tools and methodologies in rare disease settings. You will identify research needs, methodological gaps, and opportunities to advance rare disease regulatory science.

Learning Objectives: Under the guidance of a mentor, you will: 

• Gain experience applying emerging AI methods and technologies to rare disease research, drug development, and regulatory science
• Learn to develop and evaluate analytical approaches for identifying, organizing, integrating, and interpreting rare disease–related information
• Build skills in assessing the utility, performance, limitations, and applicability of emerging analytical tools and methodologies
• Develop an understanding of regulatory science considerations relevant to rare diseases and emerging technologies
• Strengthen your ability to identify research needs, methodological gaps, and opportunities for innovation in rare disease research
• Hone the skills necessary to participate alongside multidisciplinary scientists and researchers across data science, biomedical research, and regulatory science domains
• Enhance scientific communication skills through the presentation and discussion of research findings and analytical results
• Gain exposure to real-world challenges and opportunities in the application of AI to biomedical and regulatory decision-making
• Develop critical thinking skills for evaluating emerging technologies in complex and data-limited rare disease settings

Mentor: The mentor for this opportunity is Rashed Hasan (mdrashedul.hasan@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date: 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.

This 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.

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. 

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency.  This agreement covers such topics as the following:

• Non-employee nature of the ORISE appointment;
• Prohibition on ORISE Fellows performing inherently governmental functions;
• Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
• The fact that research materials and laboratory notebooks are the property of the FDA;

ORISE fellow’s obligation to protect and not to further disclose or use non-public information.