Publications that: a) describe the development and translation of technology to further regulatory science; b) applies scientific knowledge to develop practical technology or inventions or c) bridge the gap between fundamental academic science and real-world health care applications. Nominations must have an FDA staff member as the first or last author on the manuscript which must have been accepted or published in a reputable, peer reviewed journal in the last fiscal year.

 

2023

Journal Name: Science of the Total Environment
For monitioring SARS-CoV-2 and variants of concern in wastewater for over twenty months and inverstigating its genomic changes during COVID-19 pandemic.

 

Camila Siqueira Silva, Ph.D. (NCTR)
 

2022

Journal Name: Nature Biotechnology

For the development of benchmarking ctDNA reference samples and evaluation of the analytical performance of five industry-leading liquid biopsy assays for precision oncology.

 

Joshua Xu, PhD (NCTR)

 

2021

Journal: Proceedings of the National Academy of Sciences of the United States of America

For publication of the first study of macrophage distribution and dynamics in human eyes published in the Proceedings of the National Academy of Sciences.

 

Daniel X. Hammer, PhD (CDRH)

 

2020

Molecular Therapy: Methods & Clinical Development

For being the first to demonstrate that immune responses to Cas9 could have consequences for the clinical applications of Cas9-mediated gene editing.

 

Vijaya L. Simhadri, PhD

 

2019

For the novel application of a chemical assay to detecting and quantifying residual protein and microbial biofilms on surfaces.

Kenneth Scott Phillips, PhD

 

2018

For exceptional contribution in developing a novel fluorescence-based bionanosensor for rapidly detecting biologically active Clostridium botulinum neurotoxin serotypes at toxicologically relevant concentrations

 

Timothy Duncan, PhD

 

2017
For developing a publication describing a novel concept for reusing oncology drugs for rare diseases by examining similar mutations and pathways common to cancers and rare diseases. 

Zhichao Liu PhD
Hong Fang, PhD
William Slikker,PhD
Weida Tong, PhD 

2016
For exceptional contribution to applied physics and regulatory science in generating a novel
high resolution computational model of the human head and neck.

Maria Iacono, et al
Esther Akinnagbe-Zustereel, PhD Kelsey Bower, BSE
Ethan Cohen, PhD Maria Iacono, PhD Wolfgang Kainz, PhD, MS
Leonardo M. Angelone, PhD 

2015
For contributions leading to better understanding of the technical performance and clinical usefulness of next-generation sequencing technologies that prepare FDA's readiness for reviewing data from this emerging genomics technology.

Hong Fang, PhD
James C. Fuscoe, PhD
Binsheng Gong, PhD, MA (ORISE Fellow)
Huixiao Hong, PhD
Joseph Meehan
Weida Tong, PhD
Joshua Xu, MS, PhD