FDA Clinical Subtyping Based PK/PD Modeling Fellowship
*Applications will be reviewed on a rolling-basis.
SUBMIT APPLICATION THROUGH EXTERNAL LINK. SUBMIT RESUME WITH APPLICATION.
A research opportunity is available in the Office of New Drugs/Office of Hematology and Oncology Products, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
This project in the Office of New Drugs (OND) Office of Hematology and Oncology Products (OHOP) aims to characterize the clinical subtypes of Antisense Oligonucleotides (ASO)-induced thrombocytopenia by developing robust prototypes of clinical pattern-coupled pharmacokinetic and pharmacodynamic (PK/PD) models for ASO-induced thrombocytopenia. The models developed from this project will be tested in clinical trial database to evaluate their ability to predict the incidence and severity of ASO-induced thrombocytopenia. Through leveraging prior knowledge from clinical trials to develop evidence-based PK/PD profiling and predictive model development, this project will provide scientific and clinical evidence for our Agency to be able to make more informed decisions around dosing, patient selection criteria, risk management, and ultimately regulatory recommendations on ASO drugs.
Under the guidance of the mentor, the participant will train on:
- database development and characterization of clinical subtypes of (ASO)-induced thrombocytopenia
- collect data for population modeling analysis
- determine compound-specific physicochemical parameters for each product
- perform exploratory analyses on clinical subtypes of ASO-induced thrombocytopenia to provide the basis for PK/PD modeling
- perform multivariable, semi-mechanistic population PK/PD modeling for each subtype of ASO-related thrombocytopenia
This opportunity provides the participant with experience in Model Informed Drug Development, dataset building/exploratory analysis, PK/PD modeling and experience in regulatory development and clinical safety signal analysis for ASO products.
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 initial appointment is for four to six months, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
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.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0520) in your email.