FDA Clinical Pharmacology of Therapeutic Biologics Fellowship
*Applications will be reviewed on a rolling-basis.
Multiple research opportunities are available in the Office Translational Sciences/ Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) 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. This work covers more than just medicines.
The FDA's published guidance documents outline general principles regarding how to use clinical pharmacology data to support a demonstration of biosimilarity. The implementation of clinical pharmacology programs for biosimilar development depends on the characteristics of PK (and PD when appropriate). Given the diversity of therapeutic proteins in structural features and in the PK properties, the study design characteristics for the PK (or PK and PD) similarity study are determined on a product-by-product basis. This project aims to ultimately improve the efficiency in regulatory review and enhance consistency across programs by developing recommendations for clinical pharmacology study design delineated by product groups which will be more advantageous when compared to the current product-by-product approach.
The participants will gain in-depth knowledge on (1) clinical pharmacology of therapeutic proteins by reviewing the PK characteristics of approved products (CDER BLAs) and PD properties based on treatment responses measured using various biomarkers, (2) regulation and regulatory considerations for biosimilar drug development, (3) current practice of study design for clinical pharmacology studies in biosimilar programs, (4) information needed to support study design, and (5) similarities/dis-similarities in PK and PD among protein 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 one year, 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.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.