FDA Pediatric Drug Development Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Clinical Pharmacology / Division of Inflammation and Immune Pharmacology, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
Currently, FDA requires an independent Phase 3 study in pediatrics with T2DM for the approval of pediatric indication. With the previously submitted clinical studies in subjects with T2DM, a large database is available within the agency for leveraging the existing knowledge and considering an efficacy extrapolation pathway for pediatric T2DM. The aims of this research are to 1) To establish similar time course of disease progression and placebo response relationship between pediatric and adults, 2) To establish similar dose/exposure-response relationship between pediatrics and adults, and 3) To explore potential causes of failure of the clinical studies in pediatric T2DM.
The participant will have the opportunity to develop modeling and simulation skills and learn about drug development in a regulatory research environment.
Qualifications
The qualified candidate should be currently pursuing or have received a doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
A background in drug development, clinical trial design, and data analysis is desired.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0515) in your email.