FDA Research Opportunity in Therapeutic Proteins
*Applications will be reviewed on a rolling-basis.
A research opportunity is currently available in the Office of Tissues and Advanced Therapies (OTAT) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
Under the guidance of a mentor, the selected participant will join a research program that broadly studies the characteristics and immune responses to therapeutic proteins that carry non-synonymous and synonymous mutations. The participant will collaborate with experimental biologists to purify these proteins and then test them for conformation (using limited proteolytic digestion, Circular Dichroism (CD)), immunogenicity risk (by MAPPS assay or T-cell proliferation assay) and functionality.
The following articles in the literature provide examples of the range of research performed in our group:
Katneni, U.K., Liss, A., Holcomb, D., Katagiri, N., Hunt, R.C., Bar, H., Ismail, A., Komar, A.A. and Kimchi-Sarfaty, C.: Splicing dysregulation contributes to the pathogenicity of several F9 exonic point variants. Molecular Genetics & Genomic Medicine E-published; 2019; 00:e840, DOI: 10.1002/mgg3.840). 2019.
Hettiarachchi G.K., Katneni U.K., Hunt R.C., Athey J.C., Kames J.M., Bar H., Sauna Z.E., McGill J.R., Ibla J.C. and Kimchi-Sarfaty C.: Translational and transcriptional responses in human primary hepatocytes under hypoxia. American Journal of Physiology - Gastrointestinal and Liver Physiology, doi: 10.1152/ajpgi.00331.2018.
Katneni U.K., Ibla J.C., Hunt R.C., Schiller T. and Kimchi-Sarfaty C.: Von Willebrand Factor/ADAMTS13 Interactions at Birth: Implications for Thrombosis in the Neonatal Period. Journal of Thrombosis and Haemostasis 17(3):429-440, 2019.
Alexaki A., Kames J., Holcomb D.D., Athey J., Santana-Quintero L.V., Lam P.V.N., Hamasaki-Katagiri N.,Osipova E., Simonyan V., Bar H., Komar A.A., and Kimchi-Sarfaty C.: Codon and Codon-Pair Usage Tables (CoCoPUTs): Facilitating Genetic Variation Analyses and Recombinant Gene Design. Journal of Molecular Biology. https://doi.org/10.1016/j.jmb.2019.04.021. 2019.
Alexaki A., Hettiarachchi G.K., Athey J., Katneni U.K., Simhadri V., Hamasaki-Katagiri N., Nanavaty P., Lin B., Takeda K., Freedberg D., Monroe D., McGill J.R., Peters R., Kames J., Holcomb D.D., Hunt R.C., Gelinas A., Janjic N., DiCuccio M., Bar H., Komar A.A., and Kimchi-Sarfaty C.: Effects of codon optimization on protein translation and structure: Implications for protein therapeutics. 2019. Scientific Reports, in press.
Anticipated Appointment Start Date: Winter 2021
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 (FDA-CBER-2021-0003) in your email.