FDA Biologics Testing Fellowship

A research opportunity is available in the Office of Clinical Pharmacology / Division of Applied Regulatory Sciences, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

The ability to test biologics for safety and efficacy in animal models is limited by differences in biological receptors between species. The potential contribution of human-specific immune responses to the development of immunotoxicity and tissue injury hampers the assessment of product safety. Therefore, our lab seeks to develop and validate in vitro and in vivo models (including advanced humanized mouse models) that can improve FDA's ability to predict and characterize potential clinical issues in metabolism, safety and product efficacy prior to human testing. The objectives of this project are to utilize advanced in vitro, in vivo and ex vivo methods to address specific regulatory research issues associated with biological and/or biosimilar drug products.

Under the guidance of a mentor, the participant will receive training to develop advanced and novel in vitro, in vivo and ex vivo methods to address specific issues for regulatory science and learn about experimental design, testing and assessment of biologics and/or biosimilars using in vitro and in vivo models.

The qualified candidate should have received a doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date. 

If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0522) in your email.