*Applications will be reviewed on a rolling-basis.
A research opportunity is currently available in the Office of Blood Research and Review (OBRR) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
Inactivation or removal of infectious agents using pathogen reduction technologies (PRT) is a potential approach to improve the safety of the blood supply from transfusion transmitted infections (TTIs), particularly emerging TTIs. Although PRT for blood components have been investigated and, in some components, approved for use, PRT may be associated with several limitations including, inadequate inactivation of certain pathogens, suboptimal recovery of treated products, or impaired product effectiveness after transfusion. Current technologies also largely target pathogens in individual blood components (such as platelets or plasma). A more attractive, and potentially more broadly applicable approach would be to apply pathogen reduction to whole blood and then separate the parent unit into components. However, to date, there remain significant technical and scientific challenges that have limited successful use of this approach.
To address these challenges, the PRT research program at CBER aims to both:
- further characterize and advance existing technologies for pathogen reduction of whole blood, and
- to develop novel approaches to pathogen reduction of whole blood
The selected participant will contribute substantially to the research program by applying current technologies to whole blood under various experimental conditions, investigating potential effects on component biology and efficacy, and developing strategies to mitigate adverse impacts on blood components. The research will include examining the effects of pathogen reduction on in vitro parameters of component quality (such as platelet function testing, coagulation function testing, and assays of RBC function and viability).
Upon completion of the initial phases of the project, the participant will have the opportunity to extend their appointment and apply the scientific knowledge gained to novel approaches to pathogen reduction that will be investigated in the laboratory of newly established investigators at CBER/OBRR to further assess how novel approaches to pathogen reduction, including novel devices and novel biochemical approaches, impact the quality of subsequent components such as red blood cells, platelets, and plasma.
Anticipated Appointment Start Date: Fall 2021; start date is flexible
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.CBER@orau.org. Please include the reference code for this opportunity in your email.