FDA Opioid Excipient Safety Evaluation Fellowship
*Applications will be reviewed on a rolling-basis.
Two research opportunities are available with the Office of Pharmaceutical Quality / Office of Testing and Research, at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
The misuse and abuse of prescription opioids represents a major U.S. public health issue. In addition, recent post-marketing data of reformulated Opana has highlighted serious safety concerns associated with unintended use of ADF (abuse deterrent formulation) product. Among the many considered causes, the excipient used in the product (polyethylene oxide, PEO) was thought to be a major factor but there is no guideline on how to determine the safety of an excipient when used through a non-intended route of administration. The aims of this project are to better understand the relationship between excipients, manufacturing and manipulation methods and toxicological outcomes associated with non-intended use of ADF opioids and to develop in vitro tools to allow safety evaluation of ADFs.
The participant will be trained within a highly multi-disciplinary team of experts from chemistry, medical device, material science, pharmacology and toxicology, and develop deep understanding of the regulatory review and policy process. The participant will have the opportunity to be a part of the research team to develop innovative methodologies to overcome unique regulatory challenges.
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.
Qualifications
The qualified candidate should be currently pursuing or have received a bachelor's, master's or 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-2020-0530) in your email.