FDA Modeling and Simulation Fellowships

About the role

The Division of Quantitative Methods and Modeling (DQMM) in the Office of Research and Standards (ORS) within the Office of Generic Drugs (OGD), located within the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) in Silver Spring, Maryland, is seeking qualified individuals to participate in research activities that support the mission of providing high quality generic drugs to the American consumer.

Responsibilities

• Modeling and simulation of solid oral products to ensure consistency and quality of bioequivalence (BE) recommendations (e.g., physiologically based pharmacokinetic (PBPK) absorption models, in vitro - in vivo correlations and pharmacokinetic/pharmacodynamic (PK/PD) modeling) including biowaivers.
• Modeling and simulation to reduce/replace in vivo BE studies (i.e., in vivo PK BE studies, clinical endpoint or pharmacodynamic endpoint BE studies) for complex generic products and other generic products with clinical study challenges.
• Application of PBPK and/or computational fluid dynamics models to develop new BE methods for locally acting drug products administered via non-oral routes.
• Population PK modeling to support more effective in vivo study designs and methods for evaluating BE. This may include implementing sparse sampling schemes for oncology patient studies and developing alternative study designs for long-acting injectable products with shorter durations or reduced sample sizes.
• PK/PD modeling of narrow therapeutic index drugs and complex drug products and clinical trial simulation to aid risk-based BE evaluation.
• Build data infrastructure and analysis tools to increase ANDA review efficiency and quality.
• Use and development of artificial intelligence (AI), machine learning (ML) and large language models (LLMs) to help promote business intelligence in the Agency (e.g., interactive AI expert systems).
• Integration of AI/ML models with conventional/mainstream PK modeling to improve the modeling efficiency (e.g., automatic PK model selection, ML based survival analysis, etc).
• Applications and development of data analytic approaches to support complex generic drug product development and regulatory assessment, e.g., whole profile comparison, multivariate analysis, etc.

Requirements

The qualified candidate should be currently pursuing or have received a master's or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.

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.)

AND

I have read the FDA Ethics Requirements.

Qualifications

The candidate should have a strong background in quantitative analysis, modeling, and simulation. Experience with PBPK, PK/PD modeling, and AI/ML techniques is preferred.

Skills

Strong skills in programming languages such as Python, R, or MATLAB are required. Knowledge of statistical software packages like SAS or SPSS is beneficial.

Benefits

N/A

Pay

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

Schedule

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

Contact Information

If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.

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Application Instructions

To submit your application, scroll to the bottom of this opportunity and click APPLY.