*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Translational Sciences/ Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located in Silver Spring, Maryland. 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 FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
Hepatic impairment (HI) is a common co-morbidity for patients with cancer. This sub-population has a higher probability of experiencing toxicities (AEs) from oncology drugs, and biologics such as antibody drug conjugates (ADCs). This necessitates dose adjustments, which are complicated by the use of different HI classification systems (NCI-ODWG vs Child Pugh) and may lead to conflicting patient HI stratification and dose adjustments (DA). DAs for HI are further complicated for ADCs, because of the serious, potentially irreversible AEs they can mediate, and the difficulty in adjusting the effect of the payload without impacting efficacy. The fellowship will assess these issues and document guidance to better mitigate these issues and improve patient safety.
Under the guidance of a mentor, the participant will survey the currently approved oncology drugs and ADCs, for hepatic impairment studies and analyses from NDA/BLA submissions over the last 5 years. The participant will also learn to create a database consisting of nonclinical and clinical pharmacology data relevant to HI.
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 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 part-time (20 hours per week) 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 (FDA-CDER-2021-0719).