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Chief Scientist Publication Award for Methodology

Publications in this category report on a new or refined non-laboratory method and/or a new, innovative, or otherwise exceptional study design or analysis that addresses one or more public health challenges. This award recognizes the development and demonstration of an outstanding or exceptional approach to solving a public health problem. 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.
 

2024
Journal Name: British Journal of Clinical Pharmacology

For pioneering the use of a denovo pregnancy PBPK model to predict fetal exposure to sertraline and developing an accompanying web-based interactive dosing tool.

 

Christine Nguyen, M.D. (CDER)
Victor Crentsil, M.D., Dr.PH, M.H.S. (CDER)
Blessy George, Pharm.D., Ph.D. (CDER)
Miao Li, Ph.D. - Visiting Scientist (OC/OCS/NCTR)

 

2022

Journal Name: Nature Biotechnology

For study design in establishing performance matrices, reference samples, and data-sets using whole-genome, whole- exome, and single cell sequencing, resulting in three publications.

 

Wenming Xiao, PhD (CDER)

 

2021

Journal: Diabetes Care

For Study Design in investigating the risk of breast cancer among insulin glargine users.

 

Marie C. Bradley, PhD (CDER)

 

2020

JAMA Network Open

For publishing a landmark paper describing the first-of-a-kind fully virtual clinical trial that replicated an actual trial performed for FDA evidence generation.

 

Aldo Badano, PhD

 

2019

For the publication “predicting Opioid Receptor binding affinity” which highlights development of a novel multi-component modeling approach to assess the risk that some new opioid poses to public safety

 

Naomi Kruhlak, PhD

Edward Hawkins, PhD

Christopher Ellis, PhD (Staff Fellow)

Lidiya Stavitskaya, PhD

Marlene Kim, PhD

 

2018

For her publication, ‘Designing therapeutic cancer vaccine trials with delayed treatment effect, an exceptional manuscript with immediate impact that may speed availability of cancer therapies.

 

Zhenzhen Xu, PhD

 

2017
This published human PBPK model is the gold standard used by public health organizations for assessing BPA exposures from foods and the environment.

Xiaoxia Yang, PhD
Daniel R. Doerge, PhD
Justin G. Teeguarden, PhD
Jeffrey W. Fisher, PhD

2016
Genetic understanding of the underlying determinants controlling the development of anti-FIX inhibitory antibodies in Hemophilia B patients 

Zuben E. Sauna, PhD (Fellow) 

2015
For outstanding scientific research concerning the under representation of women in medical device clinical trials and appropriate use of cardiac resynchronization therapy.

Kathryn O’Callaghan, BSE
Daniel Caños, MPH, PhD
Jamie Carpenter, MSPH
Ilean Piña, MD, MPH (Contractor)
William Sanders, MD, MBA
Kimberly Selzman, MD, MPH
David Strauss, MD, PhD
Robbert Zusterzeel, MD (ORISE Fellow)

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