*Applications will be reviewed on a rolling-basis.
A research opportunity is available at the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Medical Policy/Immediate Office located in Silver Spring, Maryland and/or Rockville, Maryland.
Through the CURE ID platform and associated public-private partnership, the CURE Drug Repurposing Collaboratory (CDRC) tests whether collecting real-world experience in a systematic, accurate, and detailed manner could be valuable to the medical and scientific community. For example, by promoting drug development, better information regarding positive and negative health outcomes related to the use of existing products may help drug developers narrow potential drug candidates for study. This project will contribute to efforts to improve drug development for infectious diseases, as well as rare diseases (oncologic and non-communicable) lacking adequate approved therapy and will contribute to an understanding of how to utilize real world evidence in the drug approval process.
Under the guidance of a mentor the participant may be involved in:
- contributing to design and generation of a newsfeed on the CURE application including content generation and curation
- conducting literature reviews of infectious diseases that are in the CURE app, and expanding the literature reviews to selected rare diseases, entering the case reports identified into the CURE case report form
- helping to develop case report forms for rare diseases based on the CURE ID case report form and in collaboration with the relevant stakeholders
- refining case report forms for specific infectious diseases identified as priorities by the CURE ID Coordinating Committee
- further developing the Anti-Microbial Resistant organisms and emerging threats sections of the CURE ID platform
- assisting in the development of a complimentary electronic health record (EHR)/registry automated extraction process and corresponding case report form and data visualization tool
- participate in the creation of a patient portal where patients are able to report their treatment experiences, particularly with conditions that are chronic and symptomatic, such as Post-Acute Sequelae of COVID-19 (PASC or Long-COVID)
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 and/or the Rockville, 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.